Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00829088
First received: January 23, 2009
Last updated: February 24, 2009
Last verified: February 2009

January 23, 2009
February 24, 2009
January 2009
Not Provided
  • Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066 [ Time Frame: Until >90% of predicted total radioactivity has been recovered ] [ Designated as safety issue: No ]
  • Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma [ Time Frame: Sampling at defined timepoints during residential period from pre-dose until 168h post-dose. ] [ Designated as safety issue: No ]
  • Metabolite profile in plasma and excreta [ Time Frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829088 on ClinicalTrials.gov Archive Site
  • AZD2066 metabolites in plasma+excreta if feasable [ Time Frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. ] [ Designated as safety issue: No ]
  • Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events [ Time Frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
An Open Label, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD2066 to Healthy Male Subjects

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pain
Drug: AZD2066
1 dose oral solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
February 2009
Not Provided

Inclusion Criteria:

  • Provision of signed informed consent
  • Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

  • History of somatic disease/condition, which may interfere with the objectives of the study.
  • History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
  • Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).
Male
35 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00829088
D0475C00008, EudractCT No: 2008-006129-14
No
Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden
AstraZeneca
Not Provided
Principal Investigator: Emeline Ramos, MD AstraZeneca R&D, CPU Alderley Park, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP